…Eudamed is no longer optional but obligatory. The good news is that the data entry requirement is a Competent Authority responsibility and not a device manufacturer. The bad news for…
…Eudamed is no longer optional but obligatory. The good news is that the data entry requirement is a Competent Authority responsibility and not a device manufacturer. The bad news for…
…device into the European market. The good news is that unlike your Tom-Tom or similar GPS devices that require ongoing updates to ensure the maps are current, the IVDD does…
…device into the European market. The good news is that unlike your Tom-Tom or similar GPS devices that require ongoing updates to ensure the maps are current, the IVDD does…
…an end in sight? The bad news is that device manufactures have run out of label space and IFUs have turned into books. The good news is print on-demand is…
…an end in sight? The bad news is that device manufactures have run out of label space and IFUs have turned into books. The good news is print on-demand is…
…carried out) pursuant to this Directive or any provision of national law putting it into effect. What you need to know The good news is that device manufacturers only need…
…carried out) pursuant to this Directive or any provision of national law putting it into effect. What you need to know The good news is that device manufacturers only need…
…II. The good news is that for device manufacturers that already comply with EN ISO 13485:2003, compliance with Annex II, from a quality system standpoint, is a proverbial “cake walk.”…
…II. The good news is that for device manufacturers that already comply with EN ISO 13485:2003, compliance with Annex II, from a quality system standpoint, is a proverbial “cake walk.”…
…What you need to do Granted there is a whole bunch of information needing to be digested by device manufacturers in regards to meeting the essential requirements. The good news…
…What you need to do Granted there is a whole bunch of information needing to be digested by device manufacturers in regards to meeting the essential requirements. The good news…
…definitive reason as to why the market withdraw needs to occur. Equally frustrating is when a manufacturer’s devices are blocked from entering market or additional restrictions enacted. The good news…
…definitive reason as to why the market withdraw needs to occur. Equally frustrating is when a manufacturer’s devices are blocked from entering market or additional restrictions enacted. The good news…
…of bad news, contrary to popular belief, so Dr. D will commence with the good news first. If a review by the applicable ethics committee, within a Member State(s), views…
…of bad news, contrary to popular belief, so Dr. D will commence with the good news first. If a review by the applicable ethics committee, within a Member State(s), views…
…Representative. The good news is that device manufacturers are not required to have an EU Authorized Rep in each Member State. One will do just fine. Additionally, the EU Authorized…
…Representative. The good news is that device manufacturers are not required to have an EU Authorized Rep in each Member State. One will do just fine. Additionally, the EU Authorized…
…significant interruptions in the day-to-day activities of the recipients. What happens after a Warning Letter is received? The good news is that the US Marshalls have not shown up at…
…significant interruptions in the day-to-day activities of the recipients. What happens after a Warning Letter is received? The good news is that the US Marshalls have not shown up at…
